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One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.
A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete salpingectomy using a hand-held bipolar energy instrument |
| ||
| Complete salpingectomy using traditional suture ligation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-held bipolar energy instrument | Other | A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin levels on postoperative day one | Change in hemoglobin levels reported in gram per deciliter on postoperative day one, calculated as the difference between immediate preoperative and postoperative day 1 hemoglobin levels | preoperatively and one day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of sterilization | Proportion of sterilization procedure completed by postoperative day one | preoperatively and one day after surgery |
| Total procedure estimated blood loss | estimated blood loss calculated and documented in milliliters at the end of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 21 years or older undergoing permanent sterilization at the time of cesarean delivery at 24 weeks' gestation or beyond, 21 years old and older
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean W Thermolice, MD | Contact | 703-531-3000 | jean.thermolice@inova.org | |
| Bianca Nguyen, MD | Contact | 512-750-9573 | bianca.nguyen@inova.org |
| Name | Affiliation | Role |
|---|---|---|
| Jean W Thermolice, MD | Inova Fairfax Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical campus | Recruiting | Falls Church | Virginia | 22042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34181896 | Background | Mandelbaum RS, Matsuzaki S, Sangara RN, Klar M, Matsushima K, Roman LD, Paulson RJ, Wright JD, Matsuo K. Paradigm shift from tubal ligation to opportunistic salpingectomy at cesarean delivery in the United States. Am J Obstet Gynecol. 2021 Oct;225(4):399.e1-399.e32. doi: 10.1016/j.ajog.2021.06.074. Epub 2021 Jun 26. | |
| 30170036 |
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| Traditional suture ligation | Other | Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery. |
|
| intraoperatively |
| Adjacent organ damage | Rate of injury to abdominal/pelvic organs sustained during the procedure | intraoperatively |
| Need for blood transfusion | any need for blood products transfusion intraoperatively through discharge | from day of surgery up to 30 days pospartum |
| Total operative time | time necessary to complete the surgery from skin incision to end of skin closure | intraoperatively |
| ICU admission | any admission to the intensive care unit for procedure-related complications | from day of surgery up to 7 days postpartum |
| Length of hospital stay | Duration of hospitalization in days from admission to discharge | from day of surgery up to 6 weeks postpartum |
| Hospital readmission postoperatively | Any admission after initial discharge from the hospital | Day of initial dischage through 6 weeks postpartum |
| Reoperation rates | Number of participants who return to the operating room due to initial procedure-related complications | postoperative day 0 through 6 weeks postpartum |
| Pain score | pain severity measured on a scale of 0 through 10 | from day of surgery up to 7 days postparum |
| Surgical site infection | any infection that occurs post-surgery in the abdomen, pelvis, abdominal walls or skin | postoperative day 0 through 6 weeks postpartum |
| Cost | cost difference between bipolar instrument and suture | intraoperatively |
| Venkatesh KK, Clark LH, Stamilio DM. Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery. Am J Obstet Gynecol. 2019 Jan;220(1):106.e1-106.e10. doi: 10.1016/j.ajog.2018.08.032. Epub 2018 Aug 28. |
| 30477808 | Background | Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23. |
| 30913193 | Background | ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention. Obstet Gynecol. 2019 Apr;133(4):842-843. doi: 10.1097/AOG.0000000000003165. |
| Background | Society of Gynecologic Oncology. SGO Clinical Practice Statement: Salpingectomy for Ovarian Cancer. 2013. https://www.sgo.org/clinicalpractice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention |
| 25820366 | Background | Walker JL, Powell CB, Chen LM, Carter J, Bae Jump VL, Parker LP, Borowsky ME, Gibb RK. Society of Gynecologic Oncology recommendations for the prevention of ovarian cancer. Cancer. 2015 Jul 1;121(13):2108-20. doi: 10.1002/cncr.29321. Epub 2015 Mar 27. |
| Background | Nguyen, N. T., Alabaster, A., Simmons, S., Weintraub, M. L. R., & Powell, C. B. (2019). Opportunistic salpingectomy techniques at the time of cesarean delivery: a retrospective cohort study. Journal of Clinical Gynecology and Obstetrics, 8(3), 70-76. |
| 35843545 | Background | Lauterbach R, Gruenwald O, Matanes E, Justman N, Mor O, Vitner D, Avrahami R, Ghanem N, Zipori Y, Weiner Z, Lowenstein L. A randomized controlled trial of 2 techniques of salpingectomy during cesarean delivery. Am J Obstet Gynecol MFM. 2022 Nov;4(6):100690. doi: 10.1016/j.ajogmf.2022.100690. Epub 2022 Jul 16. |
| 20497790 | Result | Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010 Jun;94(1):1-6. doi: 10.1016/j.fertnstert.2010.03.029. |